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Ethics of Clinical Research

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Abstract

Ethics, an essential dimension of human research, is considered both a discipline and practice. For clinical research, ethically justified criteria for the design, conduct and review of a clinical investigation can be identified by obligations to both the researcher and human subjects. Informed consent, confidentiality, privacy, privileged communication and respect and responsibility are key elements of ethics in research [1].

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References

  1. Gurayaa SM. Ethics in medical research. J Microscopy Ultrastruct. 2014;2:121–6.

    Article  Google Scholar 

  2. Walters L. The oversight of human gene transfer research. Kennedy Inst Ethics J. 2000;10:171–4.

    Article  PubMed  Google Scholar 

  3. Steinbrook R. Improving protection for research subjects. N Engl J Med. 2002;346:1425–30.

    Article  PubMed  Google Scholar 

  4. Steinbrook R. Protecting research subjects: the crisis at Johns Hopkins. N Engl J Med. 2002;346:716–20.

    Article  PubMed  Google Scholar 

  5. Silverman H. Ethical issues during the conduct of clinical trials. Proc Am Thorac Soc. 2007;4(2):180–4.

    Article  PubMed  Google Scholar 

  6. Encyclopedia of Bioethics. In: Post SG, Reich WT (Eds.). 3rd Edition, Section IV. New York: Macmillan, 2004.

    Google Scholar 

  7. Saif M. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Med Assoc. 2000;284:3043–5.

    Article  Google Scholar 

  8. Nys H, Stultiëns L, Borry P, Goffin T, Dierickx K. Patient rights in EU Member States after the ratification of the Convention on Human Rights and Biomedicine. Health Policy. 2007;83(2):223–35.

    Article  PubMed  Google Scholar 

  9. Nys H. Towards an international treaty on human rights and biomedicine-some reflections inspired by UNESCO’s Universal Declaration on Bioethics and Human Rights. Hein Online; 2006.

    Google Scholar 

  10. Bhutta ZA. Ethics in international health research: a perspective from the developing world. Bull World Health Org. 2002;80(2):114–20.

    PubMed  PubMed Central  Google Scholar 

  11. Alexander D, Dommel FW. The convention on Human Rights and Biomedicine of the Council of Europe. Kennedy Inst Ethics J. 1997;7(3):259–76.

    Article  PubMed  Google Scholar 

  12. Simon-Lorda P, Tamayo-Velázquez MI, Barrio-Cantalejo I. Advance directives in Spain. Perspectives from a medical bioethicist approach. Bioethics. 2008;22(6):346–54.

    Article  PubMed  Google Scholar 

  13. Mowbray AR. Cases and materials on the European Convention on Human Rights. Oxford: Oxford University Press; 2007.

    Google Scholar 

  14. Leuprecht P. Innovations in the European system of human rights protection: is enlargement compatible with reinforcement. Transnatl Law Contemp Prob. 1998;8:313.

    Google Scholar 

  15. Garrafa V, Solbakk JH, Vidal S, Lorenzo C. Between the needy and the greedy: the quest for a just and fair ethics of clinical research. J Med Ethics. 2010;36(8):500–4.

    Article  PubMed  Google Scholar 

  16. Martín-Arribas MC, Rodríguez-Lozano I, Arias-Díaz J. Ethical review of research protocols: experience of a research ethics committee. Rev Esp Cardiol English Edn. 2012;65(6):525–9.

    Article  Google Scholar 

  17. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). E6(R1). Good clinical practice: consolidated guideline. Available at: www.ich.org. Also published in Fed Reg. 1997;62:25691–25709E7.

  18. Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harring-ton RA, Califf RM, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360(8):816–23.

    Article  CAS  PubMed  Google Scholar 

  19. Agre P, Campbell FA, Goldman BD, Boccia ML, Kass N, McCullough LB, et al. Improving informed consent: the medium is not the message. IRB: Ethics Hum Res. 2003;25(5):S9–11.

    Article  Google Scholar 

  20. Pullman D, Wang X. Adaptive designs, informed consent, and the ethics of research. Control Clin Trials. 2001;22(3):203–10.

    Article  CAS  PubMed  Google Scholar 

  21. Lilford RJ, Jackson J. Equipoise and the ethics of randomization. J R Soc Med. 1995;88(10):552.

    CAS  PubMed  PubMed Central  Google Scholar 

  22. Mielke HW. Research ethics in pediatric environmental health: lessons from lead. Neurotoxicol Teratol. 2002;24(4):467–9.

    Article  CAS  PubMed  Google Scholar 

  23. Woodward Z, Argent VP. Patient confidentiality. Curr Obstet Gynaecol. 2005;15(3):211–4.

    Article  Google Scholar 

  24. Mandl KD, Szolovits P, Kohane IS, Markwell D, MacDonald R. Public standards and patients’ control: how to keep electronic medical records accessible but private. Medical information: access and privacy. Doctrines for developing electronic medical records. Desirable characteristics of electronic medical records. Challenges and limitations for electronic medical records. Conclusions commentary: open approaches to electronic patient records. Commentary: a patient’s viewpoint. BMJ. 2001;322(7281):283–7.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  25. Fisher CB. Privacy and ethics in pediatric environmental health research—part I: genetic and prenatal testing. Environ Health Perspect. 2006;114(10):1617.

    Article  PubMed  PubMed Central  Google Scholar 

  26. Miller RA, Schaffner KF, Meisel A. Ethical and legal issues related to the use of computer programs in clinical medicine. Ann Intern Med. 1985;102(4):529–36.

    Article  CAS  PubMed  Google Scholar 

  27. Tauber AI. Patient autonomy and the ethics of responsibility. Cambridge: The MIT Press; 2005.

    Google Scholar 

  28. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use. 2008. ftp://ftp.cordis.europa.eu/pub/fp7/docs/ethical-considerations-paediatrics_en.pdf. Accessed online at 16 Oct 16 2015.

  29. Clinical investigation of medicinal products in the paediatric population. ICH E11. CPMP/ICH/2711/99. http://www.emea.europa.eu/pdfs/human/ich/271199EN.pdf.

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Cingi, C., Muluk, N.B. (2017). Ethics of Clinical Research. In: Quick Guide to Good Clinical Practice . Springer, Cham. https://doi.org/10.1007/978-3-319-44344-7_16

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  • DOI: https://doi.org/10.1007/978-3-319-44344-7_16

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